Pharmacopoeia article is a document in which the quality standards of drugs or raw materials are indicated. It also contains information on packaging, conditions, shelf life, methods of control. The document is approved by the federal authorities; therefore, it is of national importance. It includes the name of the raw materials in Russian and Latin.
Pharmacopoeia article of the enterprise
Every drug manufacturing company has a quality standard. It involves the use of drug control methods at all stages of production. Usually used technology that has been tested and registered according to the norms of the State Pharmacopoeia.
During production, all standards must be used, not lower than the requirements found in the state document. Pharmacopoeia article has a validity period, which is approved at its adoption. Usually the term is no more than 5 years. Be sure to take into account the process.
OFS
The general pharmacopeia article is the state standard for the quality of drugs. It spelled out the requirements for drugs, as well as a description of control methods. The main information is:
- list of indicators and test methods;
- chemical, physical, biological properties;
- drug requirements.
The pharmacopeia article is accepted by the department’s management, and then it is registered with the organization that carries out the production of drugs.
BSF
Private pharmacopoeial articles are documents that prescribe the quality and safety of drugs. They are published for medicines under the international nonproprietary name.
Temporary Pharmacopoeia Article
This document is issued at the time of development of the industrial manufacture of the drug. It is necessary for processing methods of establishing the quality or indicators of a new medicine for a period of not more than 3 years.
What does the article consist of?
Pharmacopoeia article includes a lot of important information. In the introductory section, you can find information about the period of collection of raw materials, as well as about its characteristics. By processing, the products are dried, threshed, freshly picked, freshly frozen. Plants can be wild and cultivated. The life form, name is indicated.
Mandatory information includes external signs that serve as confirmation of the purity and quality of products. The composition of the raw materials and signs should include a pharmacopoeial article. Medicines are also evaluated by the method of microscopy, which allows you to establish the authenticity of the product. This section includes signs of the structure of the raw materials, as well as the type of microclimate where the study was performed.
Alcohol under pharmacopeia articles, as well as other drugs are tested for various reactions or tests. This is necessary to verify the authenticity of the product. Qualitative reactions determine how verification is performed and the results.
Numeric indicators
The section consists of specific indicators and their norms:
- whole, cut, powdery raw materials are determined for quality; all medicinal raw materials must be checked;
- the presence in the preparations of active ingredients, total and insoluble ash.
number
Be sure to follow the methodology for determining the main active components in the form of an amount calculated on any quantity of a particular component. When an individual substance is obtained, its content is normalized.
Other characteristics
The document indicates the types of packaging required for all preparations, as well as the mass of the substance needed for one box. With the help of microbiological purity, the level of microorganisms and their number are detected.
Of great importance is the marking, performed on the basis of generally accepted graphic design requirements. The necessary information includes requirements for loading, unloading. The rules of competent transportation are also indicated, in which the properties of the products do not change.
The document contains information on the storage conditions of drugs, including protection against the effects of environmental factors. Important information includes the expiration date during which the medicine can be used for its intended purpose. After him, doing this is unacceptable, as this poses a threat to health. The pharmacological action section includes information about the group to which the medicine belongs.
Storage
The article has information on the proper storage of products. Special rooms must comply with all standards to ensure the preservation of the quality of drugs.
The complex of premises should consist of:
- territory of acceptance, where the unpacking, packaging of drugs;
- fundraising areas;
- quarantine facilities;
- a plot for storing special preparations;
- premises for defective and expired goods.
Each zone should be designated. It is important that the premises comply with sanitary and hygienic requirements. Legislation establishes the need to support the climate regime based on accepted standards of temperature and humidity.
The documentation contains information about the control of air exchange in the storage room for medicines. Such rooms should have natural and artificial lighting. If required, sun protection is installed. Using these and other rules is the production, storage and release of drugs.